SONIALVISION G4 is a multi-purpose X-ray R/F system — Class II medical device recall Z-0316-2025
Ongoing recall by SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, reported 2024-11-13, distributed nationwide. X-ray R/F system software with certain versions of the control board may occasionally fail to display images w
| Recall number | Z-0316-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION, Kyoto, N/A, Japan |
| Recall initiated | 2024-09-06 |
| Classified | 2024-11-07 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 3 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04540217064809, 04540217064816 |
| Serial numbers | 41C3518D7001, 41C3518E4001, 41C3536D9001 |
Product
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammography.
Reason for recall
X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0316-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.